tbuckley/cabot-search huggingface dataset:
The impact of receipt of systemic anticancer therapy (SACT) near the end of life (EOL) on cost among oncology practices participating in CMS' Oncology Care Model (OCM).
Authors: Kerin B. Adelson, Maureen Canavan, Karna Sheth, Jeffrey A. Scott, Sarah Westvold
Journal: Journal of Clinical Oncology (2023)

e18923 Background: Chemotherapy administered near the EOL is associated with higher costs due to downstream care that occurs when patients do not transition to hospice, such as hospitalizations and ICU use. Since 2015 rates of systemic therapy at the EOL have remained stable, while chemotherapy has been replaced with costly immunotherapy. Recently, we showed receipt of immunotherapy at the EOL is also associated with higher rates of acute care use than among patients who don’t receive by SACT near the EOL. Using data from practices participating in OCM, we evaluated the relationship between receipt of chemotherapy, immunotherapy, or no systemic therapy at the EOL and categories of cost. Methods: We used anonymized Integra Connect data for OCM episode claims attributed to 8 multi-site OCM practices from July 2016-December 2021 to identify decedents capable of making treatment decisions. We stratified patients by SACT type received within 30 days of death (immunotherapy (IO), chemotherapy (CT), or none) and used t-tests to compare the mean episode costs. We evaluated differences in overall costs as well as those billed under Medicare subgroups: Part A, inpatient acute care use and other services including (hospice, SNF, HHA), Part B, infusion drug administered in the ambulatory setting and medical and ED costs, and Part D, oral pharmacy costs. Results: Among 14,169 OCM decedents overall mean cost within 30 days of death was $22,215. Overall cost within 30 days of death was higher for patients receiving some form of SACT (IO: $26,072 or CT: $23,259) compared with no SACT $19,296 (table) all p &lt; 0.01). Patients who received no SACT at EOL had significantly lower Part B and D compared with both IO and CT respectively (all p &lt; 0.01). Additionally, patients who received CT had lower average part B costs $8,081 compared with patients who received IO within 30 days of death $13,951 p &lt; 0.01. Conclusions: Overall costs for patients who received IO or CT within 30 days of death were significantly higher than patients who received no SACT within 30 days of death. While IO patients had nearly twice as high mean Part B costs per episode compared with CT patients, CT patients had higher mean Part D costs per episode. Further research should explore whether these findings are generalizable to patients outside of OCM. [Table: see text]
Monoamine oxidase as a potential target for the development of new therapeutic strategies for bladder cancer.
Authors: Gabriela Cardoso de Arruda Camargo, Gabriela Oliveira, João Carlos Cardoso Alonso, Bianca Ribeiro de Souza, Bruna Nayara Nayara Silva Silva Santos, Monaliza Ávila, Isadora Manzato Roberto, Nelson Duran, Wagner José Fávaro
Journal: Journal of Clinical Oncology (2023)

e16611 Background: Bladder cancer (BC) is the most common malignancy of the urinary tract and one of the most prevalent cancers worldwide. As the overall prognosis of BC has not changed over the past 30 years, there is a pressing medical need to develop new diagnostic and therapeutic approaches. At present, efforts to deeply understand the pathogenic mechanisms that support urothelial carcinogenesis could help in identifying new therapeutic targets. Monoamine oxidases (MAOs) A and B are oxidative isoenzymes that catalyze the conversion of biogenic amines into their corresponding aldehydes and ketones through oxidative deamination. Recently, MAOs expression have been associated with metastasis and decreased overall survival in various types of cancer. However, the role of MAOs in BC is still poorly explored. This study characterized and compared the molecular profiles of MAO-A and MAO-B isoenzymes in the different histological stages of non-muscle (NMIBC) and muscle (MIBC) invasive bladder cancer, aiming the adaptation of these biomarkers as a criterion of clinical response, risk stratification and outcome prognosis. Methods: Sixty formalin-fixed paraffin-embedded samples of bladder were obtained from 34 to 96-year-old patients (mean 65 years) with BC diagnosis in University of Campinas and Paulinia Municipal Hospital/ Brazil. Subsequently, the samples were divided into 6 groups: pTis group, low-grade pTa group, high-grade pTa group, pT1 group and pT2 group; and submitted to immunohistochemistry analysis for MAO-A and MAO-B. The retrospective anonymous study was approved by the local ethics committee (Clinical Trial: RBR-6swqd2). Results: All stages and grades of NMIBC and pT2 (MIBC) showed positive immunoreactivity for both MAO-A and MAO-B. MAO-A immunoreactivities were significantly higher (p &lt; 0.01) in the high-grade pTa, pTis and pT2 groups in relation to low-grade pTa and pT1. Likewise, MAO-B immunoreactivities were remarkably higher (p &lt; 0.01) in the high-grade pTa and pT2 groups. No statistical differences were found between pTis and low-grade pTa for MAO-B. Interestingly, pT1 group showed the lowest (p &lt; 0.01) MAO-A and MAO-B immunoreactivities in relation to other stages and grades of BC, probably due to disruption of the extracellular matrix, with consequent reduction in O 2 delivery (hypoxia). Conclusions: These findings collectively characterize the contribution of MAOs in BC pathogenesis and suggest that MAOs have potential as a therapeutic target in BC.
Risk factors predictive of cervical lymph node metastasis in papillary thyroid microcarcinoma.
Authors: Liu Jie, Wang Meng, Li Wei, Yu Jingchao, Lu Jinle, Chen Yating
Journal: Journal of Clinical Oncology (2023)

e18091 Background: Papillary thyroid microcarcinoma(PTMC) is defined as a papillary thyroid carcinoma(PTC) measuring less than or equal to 10mm in its greatest diameter.It has the highest incidence among all thyroid carcinomas. However, the clinical characteristics and risk factors predictive of cervical lymph node metastasis in PTMC have not yet been fully elucidated.Our study aimed to investigate the clinicopathological characteristics for PTMC and to identify the risk factors predictive of cervical lymph node metastasis in PTMC.This study was the Medical Science Research Project of Hebei Province (NO.20210957). Methods: We retrospectively reviewed the medical records of 714 pathologically proven conventional PTMC patients who underwent lobectomy or total or near-total thyroidectomy and central neck dissection(CND),with or without lateral neck dissection(LND) in our hospital between January 2019 and December 2020.The data were analyzed in relation to age at diagnosis, gender, tumor size,capsular invasion,multifocal tumor,tumor location,and lymph node metastasis(LNM) that includes central lymph node metastasis(CLNM) and lateral lymph node metastasis(LLNM).Logistic regression model was used to investigate the risk factors for LNM in PTMC.All analyses were performed with STATA 16. Results: There were 714 patients with PTMC, consisting of 491(68.8%) women and 223 (31.2%) men.Among them,331(46.4%) were≥55 years old,and 383(53.6%) were &lt; 55 years old. 256 patients(35.9%) with tumor diameter≤5mm,and 458 patients(64.1%) with tumor diameter &gt; 5mm.Among all patients, 211(30.0%) had multifocal,capsular invasion,566(79.0%) had multiple lobes,and 20(2.8%) had hashimoto's thyroiditis.CLNM occurred in 438(61.3%),while LLNM was found in 219(30.6%).The univariate analysis showed that male gender,age＜55 years,tumor size＞5mmtumor location in the lower third of the thyroid,multifocal,capsular invasion and bilateralism were significantly associated with CLNM.Multivariate analysis showed that the capsular invasion,tumor size＞5mm,multifocal,tumor location in the lower third of the thyroid were independently correlated with CLNM.In addition,univariate analysis showed that tumor size＞5mm,tumor location in the superior pole of thyroid,multifocal,capsular invasion, bilateralism and CLNM were associated with LLNM.However,multivariate analysis showed that tumor location in the superior pole of thyroid,capsular invasion,tumor size＞5mm,and CLNM were independently correlated with LLNM. Conclusions: Capsular invasion,tumor size＞5mm,multifocal,and tumor location in the lower third of the thyroid predict increased CLNM in PTMC patients.The possibility of LLNM should be carefully evaluated for these patients with tumors located in the upper pole of the thyroid gland,capsular invasion,tumor size＞5mm,and CLNM. Clinical trial information: 20210957 .
ctDNA detection in patients with brain metastases arising from solid tumors.
Authors: Laura Alder, Gloria Broadwater, Michelle Green, Eric S. Lipp, Amanda E.D. Van Swearingen, Jeffrey Melson Clarke, Carey K. Anders, Sarah Sammons
Journal: Journal of Clinical Oncology (2023)

2027 Background: While circulating tumor DNA (ctDNA) is a routine tool for therapeutics in metastatic solid tumors, data in those with stable and active brain metastases (BrMs) is limited. We assessed genomic alterations in ctDNA from patients (pts) with solid tumor BrMs in three groups: isolated BrMs/stable extracranial disease (iCNS), concurrent brain and extracranial progression (cCNS), and extracranial progression with no active BrMs at ctDNA draw (eCNS). We also compared ctDNA alterations between pts with and without BrMs. Methods: Pts with BrMs and a Guardant 360 profile (n=253) from the Duke Molecular Registry of Tumors between 01/2014 – 12/2020 were identified. Intracranial and extracranial disease status were determined via investigator assessment (RECIST and RANO-BM criteria) within 30 days of ctDNA test. Mutant allele fraction (MAF) was defined as the % of mutant alleles divided by total alleles at a given loci. Differences in mean ranks of the MAF % maximum were compared using the Kruskal-Wallis test and pairwise comparisons with the Dwass, Steel, Critchlow-Fligner multiple comparisons post-hoc procedure. We compared differences in MAF &gt;1% using the chi-square test. Results: Among the 253 pts with BrMs: 29 (12%) had iCNS, 160 (63%) cCNS, and 64 (25%) eCNS. The two most common tumor types were breast (BC, 12.0%) and non-small cell lung cancer (NSCLC, 76.4%). Median MAF was lower in the iCNS group (1.6%) vs cCNS (4.8%) p=0.002, but eCNS did not differ (2.6%). In pts with BC BrMs, ESR1 mutations were most frequent in the iCNS group (67%), followed cCNS (54%) then eCNS (18%) (p = 0.09) as were PIK3CA mutations, iCNS(50%), cCNS (46%), and eCNS (27%), p = 0.55. In pts with NSCLC BrMs, EGFR mutations were most frequent in the iCNS followed by cCNS then eCNS (67%, 40% and 37%, p = 0.08). KRAS mutations were more frequent in cCNS followed by eCNS and iCNS (30%, 17% and 6% p = 0.031). Patients with no BrMs (n=449) included 24% breast and 76% NSCLC. In the ctDNA, ESR1 and BRCA2 mutations were more frequent in pts with BC BrMs than those without (60% vs 25%, p&lt; 0.001) and (17% vs 5%, p=0.022), respectively. Mutations in EGFR were more frequent in pts with BrMs vs without (36% vs 17%, p&lt;0.001). Sequencing from both BrMs tissue and ctDNA were available for 8 pts (4cCNS and 4 iCNS). 7 of these (87.5%) had identical mutations in tumor and ctDNA. Conclusions: This study illustrates the feasibility of detecting actionable mutations from ctDNA among pts with BrMs, with and without extracranial disease. A higher frequency of actionable mutations in several targetable genes was observed in ctDNA when comparing pts with and without BrMs, thus providing therapeutic opportunities. Additional studies comparing ctDNA and alterations in BrMs tissue are needed to determine if ctDNA can be considered a surrogate to support treatment decisions.
Curating clinical trials: Helping patients find hope by exploring clinical trial opportunities.
Authors: Rhonda Abdel-Nabi, Mahmoud Hossami, Kayla Touma, Renee Nassar, Milica Paunic, Olla Hilal, Farwa Zaib, Claire Rim, Roaa Hirmiz, Caroline M. Hamm
Journal: Journal of Clinical Oncology (2023)

6521 Background: Clinical trials are essential to the advancement of clinical therapies. However, only 5% of cancer patients enroll in clinical trials (CTs) due to limited accessibility. Given that greater participation in CTs is associated with better patient outcomes, patients from smaller centres are at a disadvantage. The Clinical Trials Navigators (CTN) program was established by Hamm (2022) to help patients in smaller communities navigate and enrol in CTs, resulting in clinical trial enrolment of 7% of patients. This study will provide updated results on the impact of the CTN program as it has expanded. Methods: Between March 2019 to September 2022, 241 patients were enrolled in the CTN program. Five Clinical Trials Navigators (CTNs) receive referrals from various sources: physicians, patients, and patient support groups. CTNs review medical information submitted and search five CT registries. Eligibility criteria is scrutinized. A second review of the CT list is conducted by two physicians to ensure accuracy. The number of potential trials is recorded at each step of review. Data collected includes: patient disease, stage, and number of prior therapies, time from referral to death, number of potential trials, number of trials that were phase I or phase II / III / IV, number of outgoing referrals, locations of the identified trials, and successful enrolment onto CTs. Patient information and results were inputted and analysed using REDCap. REB Category A approval has been granted on August 31, 2022. REB approval number is 22-439. Results: 41 Canadian cancer patients used the CTN program. The updated study found that 75.9% of patients were in stage IV of their disease, and 51% had at least two prior lines of therapy. 61.4% of patients deceased at last follow up, with a range of 0.3-37.5 months from CTN program referral to death, and a median of 5.9 months. CTNs identified a range of zero to 26 trials for each patient with a median of three trials: a range of zero to 10 phase I trials were found, and a range of one to eight phase II / III / IV trials were found. 25.5% of patients referred to a CT enrolled onto the recommended trial. The expanded CTN program resulted in CT enrolment of 8.5% of patients that follow-up information is available for. Conclusions: One quarter of patients referred to a CT by the CTN program were successfully enrolled, highlighting the CTN program as a successful tool to identify CTs for cancer patients and improve CT accrual. 8.5% of all patients with available follow-up information that participated in the CTN program were enrolled onto clinical trials. Further investigation into reasoning for early high mortality rates should be assessed. New initiatives to improve uptake of the CTN program are ongoing.
Navigating how to choose an oncologist as part of the cancer journey.
Authors: Ann Francis, Taylor Teschner, Prem R. Warde, Melissa Johlie, Lynn Buthe, Kjel Andrew Johnson
Journal: Journal of Clinical Oncology (2023)

e18877 Background: Being diagnosed with cancer and having to navigate what to do next is overwhelming. One of the initial actions that needs to be taken is choosing an oncologist. It is essential that each patient finds an oncologist they trust and who will work with them through their diagnosis and treatment. CVS Health conducted this study to gain insight into 1) how cancer patients select an oncologist and what factors weigh into choosing an oncologist and 2) treatment cost concerns. Methods: In August 2022, we conducted an online survey with consumers selected from a national online panel. Patients (n = 126) were included if they had cancer, employer health insurance and currently undergoing or having completed chemotherapy infusion, oral chemotherapy, hormone therapy or immunotherapy. Patients answered a series of questions designed to understand how they selected their oncologist. Descriptive statistics and percentages are reported. Results: Oncology diagnoses included breast (48%), colon or rectal (8%), leukemia (8%), melanoma (7%), basal cell (6%), ovarian (6%), endometrial (6%), testicular (6%), prostate (5%), lung (4%) and &lt; 3% of other cancers (patients could choose multiple diagnoses). Most (79%) patients completed treatment; 75% received or were receiving chemotherapy infusion, 63% surgery, 60% radiation therapy, 29% hormone therapy and 22% oral chemotherapy. 68% of patients responded that someone suggested/referred them to their oncologist. Of these patients, 43% stated a specialist (other than an oncologist) referred them to their oncologist, 34% said their primary care physician (PCP) referred them, while hospital/treatment center, family member/friend, insurance company and other made up the rest. 38% of respondents received a second opinion. Most (89%) patients remained with the same oncologist throughout their treatment. When selecting an oncologist, most patients identified experience (93%), being a respected oncologist (90%), reputation (86%), being in network (77%), quality measures (74%) and treatment recommendations (73%) as “Very Important” factors when choosing an oncologist. 38% of patients began to worry about medical bills when diagnosed; however, 30% were never concerned. Over half (56%) of patients reported treatment cost as the most concerning bill. 82% of patients reached their deductible during treatment, with half (54%) expecting to hit their deductible less than 3 months into treatment. 75% of respondents reported hitting their out-of-pocket maximum; 39% hit it less than 3 months into treatment. Conclusions: Specialists and PCPs are integral in referring patients to oncologists. While patients are less likely to choose their oncologists directly, they report that experience, reputation, and quality of care are essential qualities in an oncologist. Cost was not an important factor when choosing an oncologist, however, patients are concerned with medical bills, specifically treatment costs.
Incidence of hepatocellular cancer in India: Analysis of population based cancer registry data.
Authors: Harish Gopalakrishna, Bin Huang, Aju Mathew
Journal: Journal of Clinical Oncology (2023)

e16233 Background: Hepatocellular cancer (HCC) is the most common primary liver cancer and the third most common cause of cancer death globally. HCC incidence rate is declining in certain highly prevalent regions, however, continues to rise in many countries where the prevalence is currently low. To understand the trend of HCC incidence in India, we analyzed HCC incidence from various regions in India from 2004 to 2014. Methods: We obtained data on HCC incidence from the Population Based Cancer Registries (PBCR) of the National Cancer Registry Program. This registry includes data from different regions spread across India. We calculated age-standardized incidence rates (to WHO World standard population 2000) for periods of diagnosis (2004-05, 2006-08, 2009-11, and 2012-14). Results: From 2004 to 2014, HCC incidence rates increased relatively by 11%. When compared to data from 2004-2005, HCC incidence rate increased absolutely from 3 per 100,000 persons to 3.3 per 100,000 persons in 2012-2014. From 2004 to 2014, the relative increase in incidence rate was 13.3% in males and 7.4% in females. Conclusions: Rising HCC incidence rate is a cause for concern in India. Globally Nonalcoholic fatty liver disease (NAFLD) is swiftly becoming the most important cause of HCC. The rise in HCC incidence in India could be likely due to the increasing prevalence of NAFLD. Effective strategies are needed to improve surveillance and early diagnosis in patients with high risk of developing hepatocellular cancer. NAFLD preventive strategies must be an urgent public health measure in India.[Table: see text]
An observational study of donafenib as adjuvant therapy to prevent hepatocellular carcinoma recurrence after curative surgery.
Authors: Changzhen Shang, Jinyi Zhong, Xuan Luo, Jianlong Zhang, Huilong Li, Yonglin Hua, Wenliang Tan, Zhang Lei, Yajin Chen
Journal: Journal of Clinical Oncology (2023)

e16227 Background: The five-year recurrence rate of hepatocellular carcinoma (HCC) after hepatic resection is as high as 70% and remains a major clinical challenge. Many investigators have suggested adjuvant therapy to prevent HCC recurrence, and several promising outcomes have been reported. Donafenib has been approved as a standard treatment for patients with unresectable HCC in China. Here, we describe our preliminary results regarding the efficacy and safety of donafenib as an adjuvant therapy for patients with HCC after hepatectomy. Methods: This was an observational study of patients with HCC following hepatectomy treated with donafenib in routine practice at Sun Yat-sen Memorial Hospital, Sun Yat-sen University. The enrolled patients were 75 years or younger, had been diagnosed with HCC, showed no evidence of recurrence at radiological follow-up within one month after hepatectomy, and had at least one high recurrence risk factor, such as tumor diameter ≥5 cm, tumor number ≥2, microvascular invasion, or serum a-fetoprotein level before surgery ≥400 ng/mL. All of the patients had adequate hematologic, hepatic, and renal functions. The primary endpoint was recurrence-free survival (RFS), and the secondary endpoints included 6- and 12-month RFS rates, overall survival, and adverse events. Results: Seventeen patients were enrolled in this study. The median age was 56 years (range, 40–72), 88.2% were males, 82.4% with HBV, 17.6% had preoperative serum a-fetoprotein levels ≥400 ng/mL, 35.3% had tumor diameters ≥5 cm, 29.4% had tumor numbers ≥2, and 29.4% had microvascular invasion. The median follow-up time for the entire patient cohort was 16 months (95% confidence interval [CI], 11.9–20.1), and 5 of 17 patients relapsed, with a recurrence rate of 29.4%. The median RFS was not reached; the 6- and 12-month RFS rates were 88.2% and 70.1%, respectively. Treatment-related adverse events (TRAEs) occurred in 82.4% of the patients, most of which were grades 1–2. Grade 3 TRAEs, including hand-foot skin reaction and rash, were observed in three (16.4%) patients. No grade 4 or 5 TRAEs occurred. Conclusions: The findings of the present study suggest that donafenib as adjuvant therapy may be a potentially effective way to prevent HCC recurrence after curative surgery. Our findings should be validated in a larger, prospectively evaluated sample. Clinical trial information: ChiCTR2200064030 .